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The U.S. FDA identified a Class I Recall, the most serious type of recall: Medtronic has removed the Pipeline Vantage 027 device models and is updating instructions for using the Pipeline Vantage 021 device models. Find out more: fda.gov/medical-device…

The U.S. FDA issued an Early Alert: Aspiration System Issue from Calyxo. fda.gov/medical-device…

The U.S. FDA identified a Class I Recall, the most serious type of recall: Smiths Medical is recalling ORAL/NASAL Endotracheal Tubes after becoming aware that certain sizes of ORAL/NASAL Endotracheal Tube products may have a smaller diameter than expected. fda.gov/medical-device…

FDA has identified Medtronic’s removal of certain Aortic Root Cannulas due to unexpected loose material that occurred during the manufacturing process as a Class I recall, the most serious type of recall. Find out more: fda.gov/medical-device…

“Do you have questions about reporting requirements for medical device convenience kit manufacturers? Visit our new FAQ page titled Convenience Kit Reporting Requirements for Corrections, Removals, and Recalls, to learn about your responsibilities.” fda.gov/safety/recalls…

On Monday, August 4, the U.S. FDA will host a public meeting to discuss recommendations for the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI). Find out more and register today. fda.gov/medical-device…